Atrium Medical

Sr. Quality System Data Specialist

Atrium Medical$105K — $130K *
Wayne, NJ 07470In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's Degree in statistics, data science, biostatistics, mathematics, or related field.
  • 5+ years of experience in data analytics, healthcare analytics, or medical device quality.
  • Strong knowledge of statistical methods, trend analysis, and risk-based monitoring.
  • Proficiency in data visualization tools such as Power BI, Tableau, or SQL.
  • Familiarity with AI methods, including Generative AI and machine learning.
  • Excellent communication skills for both technical and non-technical audiences.
  • Problem-solving and critical thinking abilities in a cross-functional environment.

Responsibilities

  • Act as a Subject Matter Expert in statistical methods to evaluate product quality.
  • Develop and implement dashboards and visualizations for data analysis.
  • Continuously enhance insights from data visualizations using diverse data sources.
  • Present analytical findings clearly to varied audiences.
  • Identify AI opportunities for improving signal detection and data processes.
  • Collaborate on data management, connectivity, and analytics enhancements.
  • Train business partners on data interpretation and dashboard usage.

Benefits

  • Health, Dental, and Vision insurance benefits
  • 401k plan with company match
  • Paid Time Off
  • Wellness initiative & Health Assistance Resources
  • Life Insurance
  • Short and Long Term Disability Benefits
  • Health and Dependent Care Flexible Spending Accounts
  • Commuter Benefits
  • Parental and Caregiver Leave
  • Tuition Reimbursement
Full Job Description
Job Overview

The Sr. Quality Data & Analytics Specialist is responsible for transforming data into meaningful insights that support product quality, patient safety, regulatory compliance, and operational excellence within global Getinge. This role combines expertise in statistical analysis, data analytics, artificial intelligence (AI), and data integration to support businesses with pro-active signal detection, reducing patient risk.

The Senior Specialist will work closely with Legal Manufacturers, Quality, Regulatory Affairs, Medical Safety, Service, Manufacturing, and Information Technology teams to develop methods and tools to identify trends, detect emerging signals, automate manual processes, and provide actionable insights that support data-driven decision making.

This position is ideal for an analytical professional who enjoys solving complex problems, leveraging modern analytics and artificial intelligence (AI) tools, and helping business partners make informed decisions using data.

Job Responsibilities and Essential Duties

Statistical Analysis & Trending
  • Act as a Subject Matter Expert in Statistical methods, supporting legal manufacturers with selection of appropriate statistical methodologies (when needed) to evaluate product performance and quality indicators.

Data Analytics & Business Intelligence
  • Develop and implement dashboards, scorecards, and visualizations supporting analyses to identify trends, patterns, anomalies, and emerging signals within quality and post-market data.
  • Continuously improve insights of dashboards, scorecards and visualizations utilizing data from multiple business systems and tools and other sources. Design output to support action determination.
  • Present complex analytical findings in a manner understandable to both technical and non-technical audiences.
  • Support management reviews and quality performance reporting activities.

Artificial Intelligence & Automation
  • Identify opportunities to leverage AI and automation to improve the efficiency and effectiveness of signal detection, including trend analysis, data extraction, process automation, and knowledge management.
  • Evaluate emerging AI technologies and recommend practical business applications.
  • Support implementation, testing, validation, and monitoring of AI-enabled solutions.
  • Follow and help establish best practices for responsible and effective use of AI within regulated business processes.

Data Management & Integration
  • Work with data from multiple sources, including Complaint handling systems, CAPA systems, ERP systems, Service databases, Manufacturing systems (e.g. NCR), Customer feedback systems
  • Identify opportunities to improve data quality, accessibility, and usability.
  • Collaborate with IT and stakeholders to improve data connectivity and analytics capabilities.
  • Assist in developing data models and reporting structures that support business needs.

Cross-Functional Collaboration
  • Partner with Legal Manufacturers and functional stakeholders to understand business questions and analytics needs.
  • Support quality and regulatory initiatives through data-driven analyses.
  • Participate in continuous improvement projects focused on quality system effectiveness.
  • Act as a trusted resource for analytics, statistical interpretation, and AI-related opportunities.
  • Provide training and guidance to business partners on data interpretation and dashboard utilization.


Required Knowledge, Skills and Abilities
  • Bachelor's or Master's Degree in a relevant field (e.g., statistics, data science, biostatistics, mathematics, or equivalent combination of education and experience is required).
  • A minimum of 5 years relevant experience in the following fields:
    • Experience in one or more of the following areas is preferred: data analytics, data science, medical device quality, healthcare analytics, statistical techniques
  • Solid knowledge and application of Descriptive statistics, Statistical trend analysis, Hypothesis testing, Risk-based monitoring, Data visualization techniques
  • Ability to interpret complex datasets, support identification of meaningful trends and signals, & communicate statistics concepts clearly.
  • Problem solver & critical thinker with attention to detail
  • Understanding of Generative AI, Large Language Models (LLMs), Machine Learning fundamentals
  • Natural Language Processing (NLP), Predictive analytics, Data automation tools, Responsible AI principles
  • Ability to identify practical applications of AI that improve processes and efficiency.
  • Curiosity for emerging technologies and analytical methods, continuous improvement mindset
  • Ability to communicate effectively
  • Demonstrate ability to work collaboratively in a cross-functional environment.
  • Experience with one of more of the following applications: Power BI, Tableau, SQL , Python, R, Microsoft Fabric, Databricks, Snowflake, Azure analytics tools, Microsoft Copilot or similar AI platforms


Internal and External Contacts/Relationships
  • Getinge Sr Leadership and Executive Team
  • Global Process Caretakers
  • Functional Global leads in BAs (Acute Care Therapies, Surgical Workplaces, Life Science) and Service Business Areass (OpS, SSU)
  • Local Quality Managers (LQMs)/Management Representatives (MRs)
  • External Agencies including FDA, Notified Bodies, and other regulatory agencies
  • Information Technologies, including Digital & Global Technology Services


This role is open to applicants within the following areas:

Poland and US.

Salaries will be based on location.

US BASED SALARY - The minimum base salary for this position is $105,000 and the maximum salary is $130,000 plus 10% in annual bonus.

POLAND BASED SALARY - The minimum base salary for this position is

#LI-YA2 #LI-Remote

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:
  • Health, Dental, and Vision insurance benefits
  • 401k plan with company match
  • Paid Time Off
  • Wellness initiative & Health Assistance Resources
  • Life Insurance
  • Short and Long Term Disability Benefits
  • Health and Dependent Care Flexible Spending Accounts
  • Commuter Benefits
  • Parental and Caregiver Leave
  • Tuition Reimbursement

About Atrium Medical

Atrium Medical is a medical device company that develops and manufactures products for cardiovascular, surgical, and other medical applications. The company's products include vascular grafts, endovascular stent grafts, and other devices used in cardiac and thoracic surgery. Atrium Medical was founded in 1981 and has been a subsidiary of Getinge AB since 2011.
Learn more about Atrium Medical
Size
500 employees
Industry
Founded
1904

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